Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Comparative Effects Of Sensory Reweighting And Mechanical Proprioceptive Facilitation Training On Static Balance, Functional Mobility And Fall Risk In Patients With Diabetic Peripheral Neuropathy
This randomized controlled trial aims to compare the effects of Sensory Reweighting and Mechanical Proprioceptive Facilitation Training on static balance, functional mobility, and fall risk in patients with diabetic peripheral neuropathy. Study design will be a randomized clinical trial. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation. Group A will receive either sensory reweighting exercises and Group B will receive mechanical proprioceptive facilitation training using the Blueidea Deep Muscle Massage Fascial Gun BLD-888 in combination with conventional therapy for six weeks. Outcome measures will include Nintendo Wii Balance Board for Static Balance, Timed Up and Go Test for Functional Mobility, and Fall Efficacy Scale for Fall Risk. Both groups will receive 18 sessions for a period of 6 weeks. Measurements of all the outcome variables will be taken at baseline, and post treatment. Results will be analyzed by using SPSS 25.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54000
- University of Management & Technology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Patients diagnosed with Type 2 Diabetes Mellitus by a medical practioner and confirmed by using MNSI Questionnaire total score ranges from 0 to 13, with higher scores indicating greater neuropathic symptoms. A score of ≥4 indicates an abnormal/positive neuropathy screen. MNSI Physical Examination: Total score ranges from 0 to 10. A score of ≥2.5 indicates an abnormal/positive neuropathy screen.
- Both Male and Female
- Age between 40-75 years
- Duration of diabetes ≥ 5 years
- HbA1c >8%
- Able to walk independently without assistive devices Exclusion Criteria
- History of lower limb fractures, severe deformities (Claw toes / hammer toes with functional limitation, Significant limb length discrepancy, or Musculoskeletal problems (Hip osteoarthritis affecting mobility, Recent ligament injuries in 6 months, Severe plantar fasciitis)
- Active foot ulcer, infection, or gangrene
- History of recent lower limb surgery or trauma (within 6 months), including fractures, dislocations, joint replacement, ligament or tendon repair/injury, or other injuries involving the hip, knee, ankle, or foot
- Amputation of lower limb
- History of deep vein thrombosis (DVT)
- History of severe vestibular and neurological disorders (e.g., stroke, Parkinson's disease), Diabetic Retinopathy and Diabetic Nephropathy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Sensory Reweighting with conventional Physical Therapy
Sensory reweighting will be performed under four different sensory conditions including eyes closed on a firm surface, eyes open on a firm surface, eyes open on a foam surface and eyes closed on a foam surface. The exercise program will include double-leg stance, tandem stance, single leg stance, tandem walking/ forward and backward waling and sit to stand exercises without arm support. Only standing exercises will be performed on foam surface while eyes closed to ensure patient safety. Each exercise trial will be performed for 20-30 seconds under each condition with three repetitions per condition. Rest intervals of 30-60 seconds will be given between trials. The total duration of each session will be 15-20 minutes. Progression of exercise will be introduced gradually initially exercises with eyes open on firm surface during week 1-2, followed by eyes closed condition in 3-4 week and dual task activities will be introduced during week 5-6. |
Sensory reweighting will be performed under four different sensory conditions including eyes closed on a firm surface, eyes open on a firm surface, eyes open on a foam surface and eyes closed on a foam surface. The exercise program will include double-leg stance, tandem stance, single leg stance, tandem walking/ forward and backward waling and sit to stand exercises without arm support. Only standing exercises will be performed on foam surface while eyes closed to ensure patient safety. Each exercise trial will be performed for 20-30 seconds under each condition with three repetitions per condition. Rest intervals of 30-60 seconds will be given between trials. The total duration of each session will be 15-20 minutes. Progression of exercise will be introduced gradually initially exercises with eyes open on firm surface during week 1-2, followed by eyes closed condition in 3-4 week and dual task activities will be introduced during week 5-6. |
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有源比较器:Mechanical Proprioceptive Facilitation training with conventional Physical Therapy
Mechanical Proprioceptive Facilitation Training using Blueidea Deep Muscle Massage Fascial Gun BLD-888 percussion massage gun. Mechanical stimulation will be applied to the plantar surface of the foot, calf muscles, and anterior and posterior thigh muscles. The device will be applied perpendicular to the tissue at a moderate, patient-tolerable intensity level. Each treatment area will receive percussion stimulation for approximately 1-2 minutes with a total intervention duration of 8-10 minutes per session(38, 39). The intervention program will be conducted for 6 weeks, with 3 sessions per week total 18 treatment sessions. |
Mechanical Proprioceptive Facilitation Training using Blueidea Deep Muscle Massage Fascial Gun BLD-888 percussion massage gun. Mechanical stimulation will be applied to the plantar surface of the foot, calf muscles, and anterior and posterior thigh muscles. The device will be applied perpendicular to the tissue at a moderate, patient-tolerable intensity level. Each treatment area will receive percussion stimulation for approximately 1-2 minutes with a total intervention duration of 8-10 minutes per session. The intervention program will be conducted for 6 weeks, with 3 sessions per week total 18 treatment sessions. Conventional treatment Range of motion exercises (ankle, knee, toes) included knee flexion and extension, ankle dorsiflexion and plantarflexion, ankle inversion and eversion, and toe flexion and extension, Alternate weight shifting (side-to-side) Seated calf raises Heel raises with support (standing) will be given to both groups. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Functional mobility through time up go test
大体时间:baseline and after 6 weeks
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Timed Up and Go Test is a standardized test used for the assessment of functional mobility. Procedure of test includes the participant stands up from the chair, walks 03 meters, turns around, returns and sit down while the completion time is recorded in seconds. Lower completion time indicates better mobility while longer completion time indicates impaired functional mobility. Score less than 10 shows Freely Mobile, >10 indicate Mostly independent and score greater than 20 seconds is generally associated impaired mobility. The test has shown excellent intra-rater and inter-rater reliability with interclass correlation coefficient reported around 0.99, along with strong validity in older adults and patients with neurological impairments |
baseline and after 6 weeks
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Fall risk through Fall Efficacy Scale
大体时间:baseline and after 6 weeks
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Fall Efficacy Scale is a 16 item self-reported questionnaire tool which measures fear of fall and self-confidence when carrying out activities of daily life. Individuals will be asked to rate, on a four-point Likert scale, their concerns about the possibility of falling when performing 16 activities. High scores means more fear of falling and less balance self-confidence. 16-19 low concern, 20-27 moderate concern and 28-64 high concern. The tool has been shown to have very good internal consistency, as evidenced |
baseline and after 6 weeks
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static balance through
大体时间:baseline and after 6 weeks
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Nintendo Wii Balance Board was used to assess static balance. This device measured postural sway, weight-shifting ability and balance control through force-sensing technology) For the measurement of center of gravity (COG) a patient was asked to stand still on balance board and then the weight distribution over the left and right feet was evaluated (body center of gravity; BCG). As a result, the percentage of weight over each foot was recorded. The result of weight distribution was measured in the percentage on right and left and further analyzed as affected and normal side. The Basic Balance Test involved shifting weight Mediolaterally to direct the center of pressure to target areas on the display. The Wii instructions were "spread your feet apart; lean left and right to keep the red bar in blue area for three seconds". The test had five possible levels with a time limit of 30 seconds to complete all levels. |
baseline and after 6 weeks
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合作者和调查者
出版物和有用的链接
有用的网址
- <p>Sams L, Langdown BL, Simons J, Vseteckova J. The impact of protocol designs for using massage guns on lower body flexibility: A randomised cross-over design study. Journal of Bodywork and Movement Therapies. 2025 Mar 1;41:85-93.</p>
- <p>Naz S, Jamil A, Ashraf S, Tauqeer S, Akram S. Proprioceptive training and conventional physical therapy on balance and quality of life in patients with diabetic peripheral neuropathy: A randomized controlled trial. Asia Pacific Journal of Health Manageme</p>
研究记录日期
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学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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IPD 计划说明
The results data collected; de-identified individual participant data will be shared.
IPD 共享时间框架
6 months after the publication of the manuscript.
IPD 共享访问标准
The data can be requested from the corresponding author.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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